AgingHCP-S1NCT07517887
Anti-aging Efficacy Study on One Cosmetic Product Containing Mitopure
A study testing Skin care product in people with Aging and Wrinkle Appearance, run by Amazentis SA at 1 site in Germany.
Trial summary
The aim of this study is to investigate the impact of a topical product on skin health and aging Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Wrinkle Appearance
- What is being tested?
- Skin care product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2026to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent to participate in the study
- Written Informed Consent for the use of the images for marketing purposes applies to subgroup participants of study 26.0112.
- Willingness to actively participate in the study and to come to the scheduled visits
- Female
- Male, approximately 10 to 15% with little facial hair
- From 45 to 65 years of age
- Healthy skin in the test areas
- Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)
Who cannot join
- Female participants: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- Active skin disease at the test area
Show all 19Show fewer
- Documented allergies to face/eye care products or their ingredients
- Diabetes mellitus
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
- Epilepsy
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
- Regular use of tanning beds within the last 6 weeks prior to the start of the study
- Any topical medication at the test area within the last 3 days prior to the start of the study
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study
- Therapy with antibiotics within the last 2 weeks prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study
- Cosmetic surgery procedure in the test area (e.g. laser, facelift) within the last 2 years and throughout the entire course of the study
- Cosmetic surgery treatments in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and throughout the entire course of the study
- Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study and throughout the entire course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-aging Efficacy Study on One Cosmetic Product vs Untreated
The aim of this study is to investigate the impact of a topical product on skin health and aging
- Conditions
- Aging, Wrinkle Appearance
- Being tested
- Skin care product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin care productOther
The cosmetic skin care product will be applied twice daily to half of the face
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic routine | Experimental | The "cosmetic routine" arm will apply the skin care product Receives: Other: Skin care product |
| Untreated control | No intervention | The "Untreated control" arm will not apply the skin care product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydration
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 2 and 8 weeks
Measured: 8 weeks
Secondary outcomes (8)
Anti-wrinkle efficacy
Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 2 and 8 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Measured: 8 weeks
Skin barrier function
Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 2 and 8 weeks
Measured: 8 weeks
Skin firmness
Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer [mm]) after 2 and 8 weeks
Measured: 8 weeks
Skin elasticity
Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 2 and 8 weeks
Measured: 8 weeks
Clinical skin appearance
Change from baseline for skin appearance (assessed on VISIA-CR Image analysis) after 2 and 8 weeks
Measured: 8 weeks
Skin aging hallmarks
Change from baseline in skin hallmarks of aging (assessed on 22mm D-Squames® tape strips) after 2 and 8 weeks
Measured: 8 weeks
Product traits
Subjective evaluation of product traits assessed via questionnaire after 2 and 8 weeks.
Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:
2 = Fully disagree;
1 = Rather disagree;
- = Rather agree;
- = Fully agree
Measured: 8 weeks
Clinical Before-After Photography
An additional cohort of 15 participants will apply the test product to their full face. Trained graders will analyze images (assessed on VISIA-CR Image) to visually determine biological skin age after 2 and 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start22 Apr 2026
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-face design. Subjects will be divided equally in 2 treatment groups (topical product or untreated). Treatments will be randomly and balanced assigned to left and right test area.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517887
- Sponsor's protocol ID
- 26.0076-23 26.0112-23
- Acronym
- HCP-S1
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-aging Efficacy Study on One Cosmetic Product vs Untreated
- ClinicalTrials.gov ID
- NCT07517887
- Acronym / sponsor ID
- HCP-S1 / 26.0076-23 26.0112-23
- Conditions
- Aging, Wrinkle Appearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the impact of a topical product on skin health and aging
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-face design. Subjects will be divided equally in 2 treatment groups (topical product or untreated). Treatments will be randomly and balanced assigned to left and right test area.
| Arm | Type | Receives |
|---|---|---|
| Cosmetic routine | Experimental | Other: Skin care productThe "cosmetic routine" arm will apply the skin care product |
| Untreated control | No intervention | –The "Untreated control" arm will not apply the skin care product |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written Informed Consent to participate in the study
- Written Informed Consent for the use of the images for marketing purposes applies to subgroup participants of study 26.0112.
- Willingness to actively participate in the study and to come to the scheduled visits
- Female
- Male, approximately 10 to 15% with little facial hair
Key exclusion criteria (19 listed)
- Female participants: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin care productThe cosmetic skin care product will be applied twice daily to half of the face | Other | Cosmetic routine |
Primary outcome
Skin hydration
Time frame: 8 weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 2 and 8 weeks
8 secondary outcomes
Anti-wrinkle efficacy
Time frame: 8 weeks
Skin barrier function
Time frame: 8 weeks
Skin firmness
Time frame: 8 weeks
Skin elasticity
Time frame: 8 weeks
Clinical skin appearance
Time frame: 8 weeks
Skin aging hallmarks
Time frame: 8 weeks
Product traits
Time frame: 8 weeks
Clinical Before-After Photography
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin care product in people with Aging and Wrinkle Appearance, run by Amazentis SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin hydration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.